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NCT00253734 · ClinicalTrials.gov registry record · Phase 2

Immunogenicity and Safety of Different Doses of Fluzone® Influenza

A Phase 2 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
217
Enrollment target
1
Study location

NCT00253734: Completed Phase 2 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00253734 is a Phase 2 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 217 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00253734, a Phase 2 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
217 participants
Enrollment target
1
Study location

Study Summary

The purpose of this research study is to find out if giving the smaller dose of flu vaccine under the skin generates antibodies against flu compared to giving the vaccine the usual way, as a shot in the arm. If using smaller doses in this manner is effective, the current supply of vaccine could be used to make more doses to give to more people. About 217 healthy adults, 18 to 49 years of age, will participate. The study will be conducted at one site in the United States and subjects are expected to participate for about 6 months. Blood samples will be taken to assess the immune system response. Local and systemic safety will be evaluated in the 28 days following vaccination.

Conditions Studied

Interventions

  • BIOLOGICAL Fluzone®
  • BIOLOGICAL Fluzone® (IM)

Study Locations (1)

Missouri

  • Saint Louis University - St Louis

Trial Details

FieldValue
Enrollment Target 217 participants
Start Date 2005-11
Est. Completion 2006-11
Phase Phase 2

What the finished NCT00253734 record still lists

NCT00253734 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Fluzone® is the first listed.

NCT00253734 reports a single indexed study location in Missouri.

Frequently Asked Questions

What is clinical trial NCT00253734 about?

NCT00253734 is a clinical study titled "Immunogenicity and Safety of Different Doses of Fluzone® Influenza". The purpose of this research study is to find out if giving the smaller dose of flu vaccine under the skin generates antibodies against flu compared to giving the vaccine the usual way, as a shot in the arm. If using smaller doses in this manner is effective, the current supply of vaccine could be u...

What is the current status of trial NCT00253734?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 217 participants. The study started on 2005-11. Estimated completion is 2006-11.

What conditions does trial NCT00253734 study?

This clinical trial studies the following conditions: Influenza.

What interventions are being tested in trial NCT00253734?

The interventions under investigation include: Fluzone® (BIOLOGICAL), Fluzone® (IM) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00253734?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00253734 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Influenza

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00253734's enrollment target sits among peer trials

217 80th of 156 higher than 77 of 156 other Influenza trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00253734, the US trial registry maintained by the National Library of Medicine. NCT00253734 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.